Conference call and webcast today at 4:30p.m. ET
NEWARK, Calif., March 15, 2018 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (NASDAQ:CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, today announced financial results and a corporate update for the quarter and fiscal year ended December 31, 2017.
“We had a transformational year in 2017, with significant progress across clinical, operational and financial objectives, focused on advancing our pipeline,” said Sujal Shah, President and Chief Executive Officer of CymaBay. “Our lead candidate, seladelpar, generated positive proof-of-concept data in primary biliary cholangitis (PBC), demonstrating it has the potential to offer patients improved efficacy and better tolerability compared to current second line treatment. The out-licensing of our Phase 3 ready gout asset, arhalofenate, to Kowa Pharmaceuticals America allowed us to monetize the value of that asset for stockholders and devote our full attention to developing therapies for liver diseases.”
“In the second half of 2018 we plan to advance seladelpar into a Phase 3 registration study in PBC. We also plan to diversify development of seladelpar beyond PBC and into nonalcoholic steatohepatitis (NASH) with the planned initiation of a Phase 2b proof-of-concept study in the first half of the year,” continued Mr. Shah. “We have strengthened our balance sheet considerably and now have the capital required to complete our planned Phase 3 study in PBC and Phase 2b study in NASH.”
Fourth Quarter 2017 Highlights
Recent Business Highlights
Fourth Quarter 2017 Financial Results
Fiscal Year 2017 Financial Results
Conference Call Details
CymaBay management will host a conference call today at 4:30 p.m. ET to discuss fourth quarter and fiscal year 2017 financial results and provide a business update. To access the live conference call, please dial 877-407-0784 from the U.S. and Canada, or 201-689-8560 internationally, Conference ID# 13676717. To access the live and subsequently archived webcast of the conference call, go to the Investors section of the company's website at http://ir.cymabay.com/events.
About CymaBay
CymaBay Therapeutics, Inc. (CBAY) is a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet medical need. Seladelpar is a potent, selective, orally active PPARδ agonist, currently in development for the treatment of patients with primary biliary cholangitis (PBC), an autoimmune liver disease, and with nonalcoholic steatohepatitis (NASH). Two Phase 2 studies of seladelpar established proof-of-concept in PBC. CymaBay is currently planning to advance development of seladelpar into Phase 3 for PBC and Phase 2 for NASH. Arhalofenate is a potential urate-lowering anti-flare therapy that has been found to reduce painful flares in joints while at the same time lowering serum uric acid by promoting excretion of uric acid by the kidney. This dual action addresses both the signs and symptoms of gout while managing the underlying pathophysiology of hyperuricemia. Arhalofenate has been licensed in the U.S. to Kowa Pharmaceuticals America, Inc. CymaBay retains full development and commercialization rights for arhalofenate outside the U.S.
Cautionary Statements
The statements in this press release regarding the potential for seladelpar to treat PBC and NASH and the potential for arhalofenate to treat gout, the potential benefits to patients, CymaBay’s expectations and plans regarding future clinical trials and CymaBay’s ability to fund current and planned clinical trials are forward looking statements that are subject to risks and uncertainties. Actual results and the timing of events regarding the further development of seladelpar and arhalofenate could differ materially from those anticipated in such forward-looking statements as a result of risks and uncertainties, which include, without limitation, risks related to: the success, cost and timing of any of CymaBay's product development activities, including clinical trials; effects observed in trials to date that may not be repeated in the future; any delays or inability to obtain or maintain regulatory approval of CymaBay's product candidates in the United States or worldwide; and the ability of CymaBay to obtain sufficient financing to complete development, regulatory approval and commercialization of its product candidates in the United States and worldwide. Additional risks relating to CymaBay are contained in CymaBay's filings with the Securities and Exchange Commission, including without limitation its most recent Annual Report on Form 10-K and other documents subsequently filed with or furnished to the Securities and Exchange Commission. CymaBay disclaims any obligation to update these forward-looking statements except as required by law.
For additional information about CymaBay visit www.cymabay.com.
Contact:
Hans Vitzthum
LifeSci Advisors, LLC
212-915-2568
[email protected]
CymaBay Therapeutics, Inc. | ||||||
Balance Sheet Data | ||||||
(In thousands) | ||||||
December 31, | December 31, | |||||
2017 | 2016 | |||||
Cash, cash equivalents and marketable securities | $ | 97,210 | $ | 16,994 | ||
Working capital | 87,234 | 9,217 | ||||
Total assets | 104,247 | 19,359 | ||||
Facility loan | 6,098 | 8,798 | ||||
Warrant liability | 6,091 | 1,145 | ||||
Total liabilities | 19,300 | 15,422 | ||||
Common stock and additional paid-in capital | 535,507 | 426,897 | ||||
Total stockholders’ equity | 84,947 | 3,937 |
CymaBay Therapeutics, Inc. | |||||||||||||||||
Financial Results | |||||||||||||||||
(In thousands, except share and per share information) | |||||||||||||||||
Quarter Ended | Year Ended | ||||||||||||||||
December 31, | December 31, | ||||||||||||||||
2017 | 2016 | 2017 | 2016 | ||||||||||||||
(unaudited) | (unaudited) | ||||||||||||||||
Collaboration revenue | $ | 5,207 | $ | - | $ | 10,000 | $ | - | |||||||||
Operating expenses: | |||||||||||||||||
Research and development | $ | 6,669 | $ | 3,848 | $ | 18,938 | $ | 15,941 | |||||||||
General and administrative | 2,894 | 2,839 | 12,387 | 9,645 | |||||||||||||
Total operating expenses | 9,563 | 6,687 | 31,325 | 25,586 | |||||||||||||
Loss from operations | (4,356 | ) | (6,687 | ) | (21,325 | ) | (25,586 | ) | |||||||||
Other income (expense): | |||||||||||||||||
Interest income | 324 | 30 | 621 | 176 | |||||||||||||
Interest expense | (234 | ) | (328 | ) | (1,080 | ) | (1337 | ) | |||||||||
Other income (expense), net | (777 | ) | 33 | (5,773 | ) | 76 | |||||||||||
Net loss | $ | (5,043 | ) | $ | (6,952 | ) | $ | (27,557 | ) | $ | (26,671 | ) | |||||
Basic net loss per common share | $ | (0.11 | ) | $ | (0.30 | ) | $ | (0.79 | ) | $ | (1.14 | ) | |||||
Diluted net loss per common share | $ | (0.11 | ) | $ | (0.30 | ) | $ | (0.79 | ) | $ | (1.14 | ) | |||||
Weighted average common shares outstanding used to calculate basic net loss per common share | 43,970,598 | 23,447,003 | 34,903,960 | 23,447,003 | |||||||||||||
Weighted average common shares outstanding used to calculate diluted net loss per common share | 43,970,598 | 23,447,003 | 34,903,960 | 23,447,003 | |||||||||||||
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